Extension Study of the Efficacy and Safety of Deferasirox Treatment in Beta-thalassemia Patients With Transfusional Hemosiderosis (Study Amended to 2-year Duration) (ESCALATOR)
Beta-thalassemia Major, Hemosiderosis, Iron Overload
About this trial
This is an interventional treatment trial for Beta-thalassemia Major focused on measuring Transfusional hemosiderosis, Beta-thalassemia major, Deferasirox, iron overload, rare anemia, iron overload due to transfusion
Eligibility Criteria
Inclusion Criteria: Patients completing the planned 12-month core study (NCT00171171) Female patients who have reached menarche and who are sexually active must use an effective method of contraception, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation Written informed consent obtained from the patient and/or legal guardian on the patient's behalf in accordance with the national legislation Exclusion Criteria: Pregnant or breast feeding patients. Patients being considered by the investigator potentially unreliable and/or not cooperative with regard to the core study protocol, or the planned extension protocol
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Experimental
Deferasirox
Deferasirox was given orally once daily (10 to 20 mg/kg) to participants 2 years and older based on participant's body weight.